Navigation Links
Anthera Pharmaceuticals Announces Completion of Interim Analysis from Phase 3 Trial with Blisibimod for Systemic Lupus Erythematosus
Date:2/10/2015

HAYWARD, Calif., Feb. 10, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced the successful completion of an interim analysis of its Phase 3 trial (CHABLIS-SC1) of blisibimod in patients with Systemic Lupus Erythematosus and that the study should continue to completion as planned. An independent statistician conducted the interim futility analysis for the CHABLIS-SC1 study, evaluating the SRI-6 response at the 24 week time point. Enrollment in the trial is projected to conclude in mid-2015.

"While the results of the CHABLIS-SC1 interim futility analysis remain blinded to Anthera, we are very pleased that the study has passed this critical milestone and now look forward to finishing enrollment later this year," said Dr. Colin S. Hislop, Anthera's Chief Medical Officer.

Prior to the interim analysis and in response to recent input from the Company's Scientific Advisory Board following the publication of clinical data from other Lupus studies with BAFF inhibitors, the Company modified the primary endpoint of CHABLIS-SC1 from SRI-8 response to SRI-6 response, which was previously a secondary endpoint of the study.  SRI-8 will remain a key secondary endpoint of the study. The Systemic Lupus Erythematosus Response Index (SRI) is an approved endpoint recognized by the FDA for previously approved therapeutics.

"Based on the wealth of new information regarding the treatment of SLE and BAFF inhibition, we are fortunate to have had the opportunity to adjust our trial design," said Dr. Colin S. Hislop. "The SRI-6 endpoint has a history of consistency across multiple trials and represents the best possibility for success. Maintaining the SRI-8 endpoint as a key secondary endpoint can maximize our commercial opportunity for the severe patients we are enrolling in the CHABLIS-SC1 study."

Anthera has also completed a Scientific Advice Process meeting with the European Medicines Agency (EMA) regarding the blisibimod development program for the treatment of IgA Nephropathy (IgAN).  Earlier this quarter the Company obtained written feedback regarding the acceptability of a single pivotal study as the initial basis for a conditional market authorization application (MAA) in the European Union utilizing proteinuria as the primary endpoint.  In addition, the EMA also provided recommendations to address treatment duration, durability of response and need for re-treatment in the BRIGHT-SC study.  Anthera and its Japanese development partner Zenyaku Koygo Co., Ltd. plan to incorporate them in a protocol amendment prior to the planned interim analysis for the BRIGHT-SC study which will be completed later this quarter.

"We are pleased by the feedback from the EMA on the IgAN development program, which supports our global approach in IgAN.  This comes at a time when we are actively expanding our recruitment efforts throughout the world," said Dr. Colin S. Hislop.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including systemic lupus erythematosus, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis.

About Blisibimod

Anthera is developing blisibimod, a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod is a novel FC-fusion protein, or peptibody, and is distinct from an antibody. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. Abnormal elevations of B-cells and BAFF may lead to an overactive immune response, which can damage normal healthy tissues and organ systems. Multiple clinical studies with BAFF antagonists have reported the potential benefit of BAFF inhibitors in treating patients with lupus and IgAN.

About Sollpura (liprotamase)

Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.  Unlike other enzyme products for EPI, Sollpura's chemical characteristics make it ideal for formulation as either a capsule or sachet product for co-administration with a variety of food products.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2014.  Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc., dlutz@anthera.com or 510.856.5598.

 


'/>"/>
SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Anthera Pharmaceuticals to Present at Annual Jefferies Healthcare Conference
2. Anthera Pharmaceuticals Announces Personnel Changes
3. Anthera Pharmaceuticals Announces Receipt of Nasdaq Notice
4. Anthera Announces Initiation of BRIGHT-SC Phase 2 Clinical Study in IgA Nephropathy with Blisibimod
5. Anthera Pharmaceuticals Reports 2013 Second Quarter Financial Results
6. Anthera Pharmaceuticals Announces Emerging Data from Phase 2 Open-Label Extension Study to be Presented at the ACR/ARHP 2013 Annual Scientific Meeting
7. Anthera Pharmaceuticals Reports 2013 Third Quarter Financial Results, Clinical and Regulatory Update
8. Anthera Pharmaceuticals to Present at Annual Piper Jaffray Healthcare Conference
9. The Zacks Analyst Blog Highlights: Anthera Pharmaceuticals, Amgen, Eli Lilly, Actelion and InterMune
10. Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update
11. Anthera Pharmaceuticals to Present at Annual Piper Jaffray Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/16/2018)... ... 2018 , ... Cameras and monitoring are top-of-mind when people think about home ... key role in a family’s health and well-being. That’s why Home Expert Danny ... “Safe At Home” satellite media event today. , Lipford and Wolf connected with ...
(Date:10/16/2018)... PHILADELPHIA (PRWEB) , ... October 16, 2018 , ... ... and Expo from October 28-31 at the Pennsylvania Convention Center. At booth 1940, ... based software, biometric devices, mobile app, as well as their specialized Skilled ...
(Date:10/13/2018)... ... October 12, 2018 , ... David Young was ... was used in the Lockheed F22 Aircraft. Today, he announces the invention of ... which can lead to sudden cardiac death (SCD). , The Two-Dimensional Arrhythmia Monitor ...
Breaking Medicine Technology:
(Date:10/16/2018)... ... October 16, 2018 , ... With a petition (case CJ-2018-04177) filed last ... PLLC joins a series of lawsuits filed in states around the country against Massage ... Envy locations by Massage Envy’s massage therapists. , This lawsuit alleges that the ...
(Date:10/16/2018)... ... October 16, 2018 , ... Intrinsic ... simple, easy-to-use software for biopharma companies. By pairing the InTime time tracker with ... resourcing questions without spending millions of dollars implementing a complicated enterprise project management ...
(Date:10/16/2018)... , ... October 16, 2018 , ... ... 2018 – Bethesda, MD, http://www.fdanews.com/fdainspectionssummit , The 13th Annual FDA Inspections ... Inspections Summit that it sometimes feels difficult to keep up. The FDA is ...
(Date:10/16/2018)... ... 15, 2018 , ... LGC Maine Standards has expanded ... easier linearity and calibration verification. , The kit, in a simulated body ... of the reportable range for Albumin (ALB), Amylase (AMY), Cholesterol (CHOL), Creatinine (CREA), ...
(Date:10/16/2018)... , ... October 16, 2018 , ... ... that it will host the proceedings of the 4th Annual International HPV Vaccine ... symposium that runs Wednesday, May 22, 2019, through Friday, May 24, 2019, with ...
Breaking Medicine News(10 mins):